510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K852024Substantially Equivalent

Dentin Adhesive

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852024 is the FDA 510(k) clearance record for DENTIN ADHESIVE, cleared for Dentsply Intl. on . FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K852024.

Clearance record

Decision date
Received
(82 days to decision)
Review panel
Unknown
Applicant
Dentsply Intl. 570 W. College Ave., York PA
Third party review
No